Project Management Workshop

Carmen B. Jacobs, RN,OCN, CCRP

Office of Multicenter Clinical Research

Outline

• Enrollment• Source Data Collection• Data Management• Standard Operating Procedures (SOPs)• Quality Assurance• Follow-up

Enrollment General Considerations:

Know the patient population Support system

Family, friends

Barriers Socio-Economic Language Knowledge deficit Culture Transportation

Resources

Enrollment General Considerations:

Know yourself Barriers

Language Knowledge deficit Culture Pre-conceived ideas regarding the protocol (e.g.

phase 1 studies versus phase 3)

Enrollment General Considerations:

Know the diseaseKnow the protocol

Eligibility criteria

Know community resources, outreach groupsMultidisciplinary team

Source Data Collection

All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

-ICH Topic E6(R) Guidelines for Good

Clinical Practice Section 2.10

• Essential Documents– Documents that

individually and collectively permit the evaluation of the conduct of a trial and the quality of data produced.

• Source Documents– Original records that

substantiate the existence of clinical trial subjects

Data Management General Considerations:

Standard Operating Procedures (SOPs) General Considerations:

Follow-Up General Considerations:

“There is no wisdom equal to that which comes

after the event.”

- Geraldine Jewsbury